Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT06346067
Status:
RECRUITING
Last Update Posted:
2025-01-17
First Post:
2024-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723373', 'term': 'naporafenib'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D000077204', 'term': 'Temozolomide'}, {'id': 'C560077', 'term': 'trametinib'}], 'ancestors': [{'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 470}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2024-03-17', 'studyFirstSubmitQcDate': '2024-03-28', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Duration of Response (DOR) for CNS disease in participants', 'timeFrame': 'Assessed up to 24 months from time of first dose', 'description': 'Based on Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM)'}, {'measure': 'Overall Response Rate (ORR) for CNS disease in participants', 'timeFrame': 'Assessed up to 24 months from time of first dose', 'description': 'Based on Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM)'}, {'measure': 'Disease Control Rate (DCR) for CNS disease in participants', 'timeFrame': 'Assessed up to 24 months from time of first dose', 'description': 'Based on Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM)'}], 'primaryOutcomes': [{'measure': 'Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2', 'timeFrame': 'Assessed up to 6 months from time of first dose', 'description': 'Incidence and severity of treatment-emergent AEs and serious AEs'}, {'measure': 'Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2', 'timeFrame': 'Assessed up to 6 months from time of first dose', 'description': 'Objective response rate (ORR) based on assessment of radiographic imaging RECIST v1.1'}, {'measure': 'Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2', 'timeFrame': 'Study Day 1 up to Day 29', 'description': 'Maximum plasma concentration of ERAS-254 and trametinib'}, {'measure': 'Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2', 'timeFrame': 'Study Day 1 up to Day 29', 'description': 'Time to achieve maximum plasma concentration of ERAS-254 and trametinib'}, {'measure': 'Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2', 'timeFrame': 'Study Day 1 up to Day 29', 'description': 'Area under the plasma concentration-time curve'}, {'measure': "Stage 2: To compare PFS and OS for patients who are randomized to receive the combination of naporafenib + trametinib to that of patients who receive physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy)", 'timeFrame': 'Assessed up to 24 months from time of first dose', 'description': '* Progression free survival (PFS) based on assessment of radiographic imaging per RECIST v1.1\n* Survival status'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Assessed up to 24 months from time of first dose', 'description': 'Incidence and severity of treatment-emergent AEs and serious AEs'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Assessed up to 24 months from time of first dose]', 'description': 'Based on assessment of radiographic imaging per RECIST version 1.1'}, {'measure': 'Time to Response (TTR)', 'timeFrame': 'Assessed up to 24 months from time of first dose]', 'description': 'Based on assessment of radiographic imaging per RECIST version 1.1'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Assessed up to 24 months from time of first dose]', 'description': 'Based on assessment of radiographic imaging per RECIST version 1.1'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Assessed up to 24 months from time of first dose', 'description': 'Based on the assessment of radiographic imaging per RECIST version 1.1'}, {'measure': 'Plasma concentration (Cmax):Stage 1 only', 'timeFrame': 'Study Day 1 up to Day 29', 'description': 'Maximum plasma concentration of ERAS-254 and trametinib'}, {'measure': 'Area under the curve (AUC):Stage 1 only', 'timeFrame': 'Study Day 1 up to Day 29', 'description': 'Area under the plasma concentration-time curve'}, {'measure': 'Quality of Life: To assess disease and treatment-related QOL in patients with NRASm melanoma.', 'timeFrame': 'Assessed up to 24 months from time of first dose', 'description': 'Using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire \\[QLQ\\]-C30 subscales and PRO CTCAE® symptom items specific to the potential cutaneous toxicities.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melanoma', 'NRAS Mutant', 'Cutaneous Melanoma'], 'conditions': ['Advanced or Metastatic NRAS-mutant Melanoma']}, 'descriptionModule': {'briefSummary': "Stage 1: To select the optimal dose of naporafenib + trametinib to be studied in Stage 2.\n\nStage 2: To compare progression free survival (PFS) and overall survival (OS) for patients with NRAS-mutant (NRASm) melanoma who are randomized to receive the combination of naporafenib + trametinib to that of patients who are randomized to physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy).", 'detailedDescription': "SEACRAFT-2 is a global, Phase III, open-label, randomized study to assess the efficacy and safety of naporafenib administered with trametinib compared to physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy) in patients with unresectable or metastatic NRAS mutant melanoma who have progressed on, or are intolerant to, an anti-programmed death-1 ligand 1 (PD 1/L1)-based regimen. The study will consist of 2 stages: dose optimization in Stage 1 and the Phase 3 portion in Stage 2.\n\nA total of approximately 470 eligible patients will be randomized to receive study drug(s) in this study across 2 stages."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Willing and able to provide written informed consent\n2. Age ≥ 18 years\n3. Histologically or cytologically confirmed unresectable or metastatic cutaneous (includes acral) melanoma.\n4. Documentation of an NRAS mutation (tumor tissue or blood) prior to first dose of study drug(s) as determined locally with an analytically validated assay in a certified testing laboratory.\n5. Archival tumor tissue collected within 5 years prior to enrollment must be confirmed to be available at the time of Screening, which may be submitted before or after enrollment for exploratory biomarker analysis.\n6. Must have received an anti-PD-1/L1 based regimen (monotherapy or combination). Patient must have documented disease progression either while receiving therapy or within 12 weeks of last dose of the most recent anti-PD-1/L1 based regimen; the patient is eligible if they have received other therapies between the most recent anti-PD-1/L1 based regimen and enrollment.\n7. ECOG performance status 0, 1 or 2\n8. Presence of at least 1 measurable lesion according to RECIST v1.1\n9. Able to swallow oral medication.\n\nKey Exclusion Criteria:\n\n1. Patients with uveal or mucosal melanoma\n2. Prior therapy with an ERK-, MEK-, RAF-, or RAS-inhibitor\n3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug(s) (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)\n4. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndrome)\n5. LVEF \\<50%\n6. Symptomatic CNS metastases that are neurologically unstable. Patients with controlled CNS metastases are eligible.\n7. Patients receiving treatment with herbal medicine known to cause liver toxicity, which cannot be discontinued 7 days prior to first dose of study drug(s) and for the duration of the study.\n8. Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial'}, 'identificationModule': {'nctId': 'NCT06346067', 'briefTitle': 'A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Erasca, Inc.'}, 'officialTitle': "A Randomized, Open-label Phase III Study in Patients With Previously Treated Unresectable or Metastatic NRAS Mutant Cutaneous Melanoma Comparing the Combination of Naporafenib + Trametinib to Physician's Choice of Therapy (Dacarbazine, Temozolomide or Trametinib Monotherapy) With a Dose Optimization lead-in [SEACRAFT-2]", 'orgStudyIdInfo': {'id': 'ERAS-254-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage 1 Dose selection Lead-in Arm 1', 'description': 'Naporafenib + Trametinib Naporafenib (ERAS-254) 100 mg administered orally twice daily (BID) Trametinib 1 mg once daily (QD)', 'interventionNames': ['Drug: Naporafenib', 'Drug: Trametinib']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1 Dose selection Lead-in Arm 2', 'description': 'Naporafenib + Trametinib Naporafenib (ERAS-254) 400 mg administered orally twice daily (BID) Trametinib 0.5 mg once daily (QD)', 'interventionNames': ['Drug: Naporafenib', 'Drug: Trametinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stage 1 Dose selection Lead-in Arm 3 Trametinib monotherapy', 'description': 'Trametinib 2 mg once daily (QD)', 'interventionNames': ['Drug: Trametinib']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2 Arm A', 'description': 'Naporafenib + Trametinib Naporafenib (ERAS-254) BID oral administration with Trametinib QD at the dose selected in Stage 1', 'interventionNames': ['Drug: Naporafenib', 'Drug: Trametinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': "Stage 2 Arm B - Physician's Choice", 'description': '* Dacarbazine 1000 mg/m2 intravenously (IV) on Day 1 of each 21-day cycle OR\n* Temozolomide 200 mg/m2/day PO on Day 1 to Day 5 of each 28-day cycle OR\n* Trametinib monotherapy, 2 mg PO QD', 'interventionNames': ['Drug: Dacarbazine', 'Drug: Temozolomide', 'Drug: Trametinib']}], 'interventions': [{'name': 'Naporafenib', 'type': 'DRUG', 'otherNames': ['ERAS-254', 'LXH254'], 'description': 'Naporafenib (ERAS-254) is an experimental Pan-Raf inhibitor', 'armGroupLabels': ['Stage 1 Dose selection Lead-in Arm 1', 'Stage 1 Dose selection Lead-in Arm 2', 'Stage 2 Arm A']}, {'name': 'Dacarbazine', 'type': 'DRUG', 'otherNames': ['DTIC'], 'description': 'Dacarbazine IV - Day 1', 'armGroupLabels': ["Stage 2 Arm B - Physician's Choice"]}, {'name': 'Temozolomide', 'type': 'DRUG', 'otherNames': ['Temodar', 'TMZ'], 'description': 'Temozolomide 200 mg/m2/day PO on Day 1 to Day 5 of each 28-day cycle', 'armGroupLabels': ["Stage 2 Arm B - Physician's Choice"]}, {'name': 'Trametinib', 'type': 'DRUG', 'otherNames': ['Mekinist'], 'description': 'Trametinib is an FDA approved anticancer medication that targets MEK1 and MEK2.', 'armGroupLabels': ['Stage 1 Dose selection Lead-in Arm 1', 'Stage 1 Dose selection Lead-in Arm 2', 'Stage 1 Dose selection Lead-in Arm 3 Trametinib monotherapy', 'Stage 2 Arm A', "Stage 2 Arm B - Physician's Choice"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic - Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Melanoma and Skin Care Institute', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '70121', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic - Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Miami Sylvester Cancer', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '66205', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Kansas Cancer Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '70121', 'city': 'Jefferson', 'state': 'Louisiana', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Ochsner Clinic Foundation', 'geoPoint': {'lat': 29.96604, 'lon': -90.15313}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '70121', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'SCRI Oncology Partners (formerly Tennessee Oncology)', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Texas Oncology- Austin Midtown', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Texas Oncology - Baylor Charles A. Sammons Cancer Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The University of Utah - Huntsman Cancer Institute (HCI)', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23502-1871', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Virginia Oncology Associates', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '2298', 'city': 'Waratah', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Calvary Mater Newcastle', 'geoPoint': {'lat': -32.90667, 'lon': 151.72647}}, {'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Tasman Health Care', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Institute', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Hollywood Private Hospital', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '3004', 'city': 'Melbourne', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'B3J 3R4', 'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Queen Elizabeth II Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'H4A3J1', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '65653', 'city': 'Brno', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 'Masarykuv Onkologicky Ustav-MOU', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '50005', 'city': 'Nový Hradec Králové', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Hradec Kralove', 'geoPoint': {'lat': 50.18185, 'lon': 15.85387}}, {'zip': '1502', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 'Sanatorium Profesora Arenbergera', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '33075', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire (CHU) de Bordeaux - 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